Warning on pneumothorax with enteral access system

Recalls, warnings, and alerts

An alert that more than 50 reports of pneumothorax events have been associated with
feeding tube-placement procedures using the Cortrak 2 Enteral Access System by Corpak
MedSystems. Most of the pulmonary events required urgent intervention, such as needle decompression
or chest tube placement, and several were associated with cardiopulmonary arrest and
death. There was also one report of nonfatal pneumothorax associated with the Kangaroo
Feeding Tube with IRIS Technology by Covidien. Although pneumothorax is known as a
rare complication of “blind” feeding tube insertion, the FDA alert noted
that using enteral access systems does not eliminate this risk.

Photo by Thinkstock.

An alert that anaphylaxis, anaphylactic shock, and other serious hypersensitivity
reactions have been reported with the use of rolapitant (Varubi) injectable emulsion. Most of the reactions occurred within the first few minutes of infusion, and some
required hospitalization. Clinicians should consult with patients to detect any hypersensitivity
to the drug's components, including soybean oil, and avoid use in patients with potential
hypersensitivity.

A recall of all sterile drug products by PharMEDium Services due to a lack of sterility
assurance. PharMEDium initially recalled 55 lots but has expanded the recall to all unexpired
lots compounded at the company's Memphis facility.

A recall of one lot of linezolid injection (600 mg/300 mL flexible infusion bags)
by AuroMedics Pharma due to the presence of mold. The batch containing white particulate matter was distributed to hospitals from May
15 through Aug. 14, 2017.

A recall of one lot of clopidogrel tablets USP (75 mg) by International Laboratories
due to mislabeling. The product is labeled as containing clopidogrel tablets USP (75 mg) but may contain
simvastatin tablets USP (10 mg).

A recall of one lot of ampicillin and sulbactam for injection USP (1.5 g in single-dose
vials) due to the presence of glass particles. AuroMedics Pharma shipped the lot to hospitals nationwide on Feb. 9, 2017.

A class I recall of the Agilis Steerable Introducer Sheath by Sterilmed due to improper
seal of the sheath hub. An inadequate seal may cause failure of the product's hemostatic valve, allowing blood
to leak through the hub, causing the cap to fall off during the procedure, or creating
a difference in pressure that allows air into the circulatory system. Recalled products
were manufactured and distributed between Jan. 1 and May 5, 2017.

Miscellaneous

A removal of the boxed warning about asthma-related death from the drug labels of
medications containing both long-acting beta-agonists (LABAs) and inhaled corticosteroids
(ICS). The FDA reviewed four safety trials of more than 41,000 patients, which showed that
using LABAs in combination with ICS to treat patients with asthma did not lead to
more serious asthma-related side effects (e.g., hospitalization, intubation, or death)
compared to using ICS alone. The trials also assessed efficacy and found that using
LABA/ICS combination therapy reduced asthma exacerbations compared to using ICS alone.

An updated product label for the cancer drug nilotinib (Tasigna) that includes information
about how to discontinue the drug in certain patients. Under the updated recommendations, certain patients with early-phase chronic myeloid
leukemia who have taken the drug for three years or more and have responded to treatment
may be eligible to discontinue the drug. Any treatment discontinuation must be followed
by regular monitoring for disease recurrence.

Approvals

Angiotensin II (Giapreza) injection for intravenous infusion to increase blood pressure
in adults with septic or other distributive shock. A trial of 321 patients with shock and critically low blood pressure found that the
treatment increased blood pressure when added to conventional approaches to increase
blood pressure. Significantly more patients responded to the injection compared to
those treated with placebo. The drug can cause dangerous blood clots with such consequences
as deep venous thrombosis, so clinicians should use prophylactic treatment for clots.

Marketing of the Dermapace System, the first shock-wave device intended to treat diabetic
foot ulcers. The device is intended to be used with standard diabetic ulcer care in patients ages
22 years and older presenting with ulcers lasting for more than 30 days. The system
uses pulses of energy to mechanically stimulate chronic, full-thickness diabetic foot
ulcers with wound areas measuring no more than 16 cm2, or about the size of a soda-can top. Treatable wounds may extend through the epidermis,
dermis, tendon, or capsule, but without bone exposure. In two randomized, double-blind
studies of a total of 336 patients receiving usual wound care (including wet-to-dry
dressings or debridement as needed) plus either the shock-wave therapy or sham therapy,
patients who had between one and seven treatments with the system had an increase
in wound healing at 24 weeks, with a 44% wound-closure rate compared to a 30% rate
with sham treatment. The most common side effects were pain during application of
the device, local bruising and numbness, migraines, nausea, fainting, wound infection,
cellulitis, osteomyelitis, and fever.

The GammaPod, a noninvasive stereotactic radiotherapy system to treat breast cancer. The system delivers a radiation dose to specific areas of the breast in conjunction
with breast-conserving treatment. It has not been shown to be as effective as whole
breast radiation therapy and is not intended as a replacement. In a clinical study
of 17 patients, the system delivered the prescribed dose to breast tumors with minimal
radiation-induced side effects, such as skin redness and erythema.

ACP Hospitalist provides news and information for hospitalists, covering the major issues in the field. All published material, which is covered by copyright, represents the views of the contributor and does not reflect the opinion of the American College of Physicians or any other institution unless clearly stated.